A Phase 1b/2 Study of AMG 655 in Combination With Paclitaxel and Carboplatin for the First-Line Treatment of Advanced Non-Small Cell Lung Cancer

NCT ID: NCT00534027

Last Updated: 2016-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 172 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2011-03-31

Brief Summary

Part 1 is complete. Part 2 is a multi-center, randomized, double-blind, placebo-controlled, phase 2 segment that will commence upon identification of the maximum tolerated dose in part 1. The Primary objective of Part 2 of the study is to estimate efficacy in combination with carboplatin and paclitaxel. Subjects will be randomized at a 1:1:1 ratio to 1 of 3 treatment arms. Subjects in each of the 3 arms will receive up to 6 cycles of paclitaxel/carboplatin (at the same dose and schedule in part 1) in combination with either AMG 655 at the maximum tolerated dose (Arm 1), AMG 655 at a lower dose (Arm 2), or AMG 655 placebo (Arm 3) IV Q3W. Randomization will be stratified by ECOG (0 or 1) and disease stage (IIIb or IV/recurrent).

Conditions

Non-Small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Arm 2

Low Dose AMG 655 with paclitaxel/carboplatin

Group Type: EXPERIMENTAL

AMG 655

Intervention Type: DRUG

AMG 655 is a monoclonal antibody directed against TR-2.

Arm 3

Placebo with paclitaxel/carboplatin

Group Type: PLACEBO_COMPARATOR

AMG 655 placebo

Intervention Type: OTHER

Inactive dummy AMG 655 (to maintain blind)

Arm 1

AMG 655 High doseplus paclitaxel/carboplatin

Group Type: EXPERIMENTAL

AMG 655

Intervention Type: DRUG

AMG 655 is a monoclonal antibody directed against TR-2.

Interventions

AMG 655

AMG 655 is a monoclonal antibody directed against TR-2.

Intervention Type: DRUG

AMG 655 placebo

Inactive dummy AMG 655 (to maintain blind)

Intervention Type: OTHER

Other Intervention Names

Placebo

Eligibility Criteria

Inclusion Criteria

• Disease Related

• Histologically or cytologically confirmed non-small cell lung cancer.
• Subjects must have advanced non-small cell lung cancer defined as stage IIIB with malignant pleural effusion or stage IV or recurrent disease.
• Planning to receive up to 6 cycles of chemotherapy
• Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 Demographic
• Men or women > 18 years of age Ethical
• Adequate Hematological, renal, hepatic and coagulation function General
• Plan to begin protocol specific therapy < 7 days after enrollment/randomization

Exclusion Criteria

• Disease Related

• Untreated or symptomatic central nervous system metastases. Subjects with a history of brain metastases are eligible if definitive therapy has been administered (surgery and/or radiation therapy), there is no planned treatment for brain metastasis and the subject is clinically stable and off corticosteroids for at least 14 days before enrollment/randomization.
• Prior chemotherapy as follows:
• Any prior chemotherapy for advanced non-small cell lung cancer
• Any prior adjuvant chemotherapy for non-small cell lung cancer < 52 weeks prior to enrollment/randomization. Adjuvant chemotherapy completed > 52 weeks prior to randomization is permitted.
• Any prior chemoradiation.
• Central (chest) radiation therapy < 28 days prior to randomization, radiation therapy for peripheral lesions < 14 days prior to enrollment/randomization
• Other abnormal medical conditions
• Documented myocardial infarction or unstable/uncontrolled cardiac condition
• History of arterial thrombosis, pulmonary embolus, deep vein thrombosis or hemorrhagic disorders
• Major surgical procedure < 30 days prior to enrollment/randomization or not yet recovered from prior major surgery, Minor surgical procedure < 7 days prior to enrollment/randomization or not yet recovered from prior minor surgery

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amgen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

MD

Role: STUDY_DIRECTOR

Amgen

References

Paz-Ares L, Balint B, de Boer RH, van Meerbeeck JP, Wierzbicki R, De Souza P, Galimi F, Haddad V, Sabin T, Hei YJ, Pan Y, Cottrell S, Hsu CP, RamLau R. A randomized phase 2 study of paclitaxel and carboplatin with or without conatumumab for first-line treatment of advanced non-small-cell lung cancer. J Thorac Oncol. 2013 Mar;8(3):329-37. doi: 10.1097/JTO.0b013e31827ce554.

Reference Type: DERIVED

PMID: 23370314 (View on PubMed)

Related Links

http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

20060295

Identifier Type: -

Identifier Source: org_study_id